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Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00290927
First received: February 10, 2006
Last updated: August 25, 2009
Last verified: March 2009

February 10, 2006
August 25, 2009
December 2003
Not Provided
  • Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)
  • Safety of HMR1964
  • - Superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy in terms of the change in HbA1C from baseline to endpoint.
  • - Safety of HMR1964.
  • - Superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy in terms of the change in HbA1C from baseline to endpoint.
Complete list of historical versions of study NCT00290927 on ClinicalTrials.gov Archive Site
change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).
- Comparison of HMR1964 intensive therapy (mono- or OHA combination therapy) with OHA therapy in terms of the change in HbA1C from baseline to week 16, consecutive change in HbA1C by every 4 weeks, plasma glucose parameters, symptomatic hypoglycemia.
Not Provided
Not Provided
 
Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-week, Multinational, Multicenter Study
  • To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
  • To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
  • To evaluate the safety of HMR1964.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: insulin glulisine
Not Provided
Kawamori R, Iwamoto Y, Kadowaki T, Iwasaki M, Kim SW, Woo JT, Baik SH, Yoon KH. Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jul 13; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
Not Provided
Not Provided

Inclusion Criteria:

  • Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI < 30 kg/m2 , a HbA1C of > 8.0 - < 11.0% at screening
  • Fasting serum C-peptide at screening > 0.7 ng/mL
  • Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent
  • Glibenclamide > 5 mg/day
  • Glimepiride > 3 mg/day
  • Gliclazide > 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
  • Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week

Exclusion Criteria:

  • Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964
  • Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products
  • Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
  • Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00290927
EFC6168
Not Provided
Not Provided
Sanofi
Not Provided
Study Director: Masayoshi KOYAMA Sanofi
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP